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NCT Number: NCT01356901

Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Herne, 44623, Germany

About this study

Sampling Method: Probability Sample (consecutive patient sampling)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
  • Written informed consent

Exclusion criteria

  • All relevant conditions according to Summary of product characteristics (SmPC)
  • Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
  • Patients currently included in any investigational trial on CHB

Treatment and study plan

Primary outcomes

  1. Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.

    Time frame: After 2 years

    A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit.

Secondary outcomes

  1. Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)

    Time frame: After 2 years

  2. Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)

    Time frame: After 2 years

  3. Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss

    Time frame: After 2 years

    Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT)

  4. Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs

    Time frame: After 2 years

  5. Number of participants with occuring resistances based on results from resistance tests

    Time frame: After 2 years

  6. Assessment of Health Status (SF-12® Health Survey)

    Time frame: Assessment of Health Status (SF-12 Health Survey) at year 1

  7. Assessment of Health Status (SF-12® Health Survey)

    Time frame: Assessment of Health Status (SF-12 Health Survey) at year 2

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 20, 2011
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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